Coordinate the planning and execution of validation/applicability, optimization, and transfer programs for analytical methodologies (pharmacopoeial and non-pharmacopoeial) for new developments, reformulations, and raw materials, both in internal and external national and international laboratories.
Define strategies based on risk analysis, pharmacopoeias, standards, and literature.
Review and approve protocols and reports, ensuring compliance with GLP, GDP, and GMP, as well as the proper execution by the personnel in charge.
Manage material resources, equipment, and supplies, guaranteeing compliance with the area's programs.
Participate in internal and external audits related to the area.
Provide technical support to formulation, development, production, and quality.
Manage special projects and urgent analytical validation requests.
Prepare and update area documentation in accordance with GLP, GDP, and GMP.
Ensure the planning and execution CAPEX process, calibration, maintenance, and qualification programs for equipment in coordination with internal areas and suppliers. Ensure the training of staff under your supervision.
Maintain and report project and operational dashboards (scope, responsible party, milestones, dates, and status) to management and leadership.
Ensure appropiate training and competency development programs for chemists
Bachelor's degree in: Pharmaceutical Chemistry, Biological Engineering, Pharmaceutical Engineering, or related field
Desirable:
1) Diploma in Validation and Applicability of Pharmacopoeial and Non-Pharmacopoeial Analytical Methods.
2) Diploma in Analytical Transfers.
3) Course in the operation of analytical equipment and instruments, Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
Skills:
a) Problem-solving, interpersonal, teamwork, project management, and communication (both oral and written).
b) Must be flexible, capable of managing multiple projects simultaneously, and work well under pressure.
c) Possess the ability to use sound judgment to handle unforeseen situations with an entrepreneurial attitude and the capacity to conceptualize and implement innovative solutions.
d) Be self-motivated and work independently. e) Maintain a service-oriented attitude towards internal clients, constantly devising ways to help them achieve their goals.
a) Knowledge of pharmacopoeias, FEUM, USP, EMA, BP, and ICH guidelines Q2, Q14, Q10, Q6, Q1, and Q3.
b) Knowledge of NOM 059, 241, and 073.
c) Knowledge and use of statistical tools.
d) Knowledge of laboratory investigations, including aberrant or atypical data.
e) Validation of manufacturing processes (desirable).
f) Validation of sterilization processes (desirable).
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
